Laparoscopic CholecystectomyPhase 4NCT01046071
The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy
A Phase 4 study testing transversus abdominis plane block in people with Laparoscopic Cholecystectomy, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether Transversus abdominis plane block as part of a multimodal postoperative regimen is superior to control in analgesic efficacy after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Feb 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic cholecystectomy
- ASA 1-3
- BMI 18-35
- Written consent
Who cannot join
- Do not understand danish
- Drug allergy
- Pregnancy
- Alcohol or drug abuse
- Chronic pain with consumption of opioids
- Consumption of NSAID, COX2inhibitors or paracetamol within 24 hours before the investigation
- Infection at the needle site.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Glostrup University Hospital, Department of anesthesia
Glostrup Municipality, 2600
About this study
Official title: The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
The purpose of this study is to determine whether Transversus abdominis plane block as part of a multimodal postoperative regimen is superior to control in analgesic efficacy after laparoscopic cholecystectomy.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- transversus abdominis plane block, TAP block placebo
- Keywords
- Transversus abdominis plane block, postoperative pain.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversus abdominis plane blockProcedure or surgery
Also called Naropine, Postoperative pain, UL-guided nerve block
UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose.
TAP block placeboProcedure or surgery
Also called placebo block
UL-guided TAP block with 20 ml of saline bilaterally, single dose.
| Study group | Role | What they receive |
|---|---|---|
| transversus abdominis plane block | Experimental | transversus abdominis plane block with ropivacaine Receives: Procedure: transversus abdominis plane block |
| block with saline | Placebo comparator | 20 ml of isotonic saline bilateral Receives: Procedure: TAP block placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during cough.
Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,24 hours postoperative.
Measured: 0,2,4,6,8,24 hours postoperative
Secondary outcomes (4)
Pain during rest
Area under the curve (AUC)-pain during rest based on measurements at 0,2,4,6,8,24 hours postoperative.
Measured: 0,2,4,6,8,24 hours postoperative
Total opioid consumption
Morphine consumption 0-2 hours postoperative. Ketobemidone consumption 2-24 hours postoperative.
Measured: 0-24 hours postoperative
Postoperative nausea and vomiting
Nausea scores (0-3) at 0,2,4,6,8,24 hours postoperative. The number of vomits 0-2, 2-4, 4-6, 6-8 and 8-24 hours postoperative
Measured: 0,2,4,6,8,24 hours postoperative
Sedation
Sedation scores (0-3) at 0,2,4,6,8,24 hours postoperative
Measured: 0,2,4,6,8,24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pernille Lykke Petersen, Glostrup University Hospital, Copenhagen
- Investigators
- Pernille L Petersen, MD, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046071
- Sponsor's protocol ID
- SM1-plp-09
- Other IDs
- 2009-017420-75, 2009
- Status last verified
- Nov 2011
- First submitted
- 8 Jan 2010
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01046071
- Acronym / sponsor ID
- SM1-plp-09
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Transversus abdominis plane block, postoperative pain.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Transversus abdominis plane block as part of a multimodal postoperative regimen is superior to control in analgesic efficacy after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transversus abdominis plane block | Experimental | Procedure: transversus abdominis plane blocktransversus abdominis plane block with ropivacaine |
| block with saline | Placebo comparator | Procedure: TAP block placebo20 ml of isotonic saline bilateral |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Laparoscopic cholecystectomy
- ASA 1-3
- BMI 18-35
- Written consent
Key exclusion criteria (7 listed)
- Do not understand danish
- Drug allergy
- Pregnancy
- Alcohol or drug abuse
- Chronic pain with consumption of opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transversus abdominis plane blockAlso: Naropine, Postoperative pain, UL-guided nerve blockUL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose. | Procedure or surgery | transversus abdominis plane block |
| TAP block placeboAlso: placebo blockUL-guided TAP block with 20 ml of saline bilaterally, single dose. | Procedure or surgery | block with saline |
Primary outcome
Pain during cough.
Time frame: 0,2,4,6,8,24 hours postoperative
Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,24 hours postoperative.
4 secondary outcomes
Pain during rest
Time frame: 0,2,4,6,8,24 hours postoperative
Total opioid consumption
Time frame: 0-24 hours postoperative
Postoperative nausea and vomiting
Time frame: 0,2,4,6,8,24 hours postoperative
Sedation
Time frame: 0,2,4,6,8,24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2011.
Related trials for Laparoscopic Cholecystectomy
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruiting
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernille L Petersen, MD principal investigator
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transversus abdominis plane block in people with Laparoscopic Cholecystectomy, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during cough. (time frame: 0,2,4,6,8,24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2011.